Status:
COMPLETED
Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients
Lead Sponsor:
Baylor Research Institute
Conditions:
Post-operative Pain
Respiratory Depression
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoraci...
Detailed Description
Dexmedetomidine has sedative and analgesic properties that may reduce the opioid requirement in post-operative patients, thereby decreasing the chance of post-operative respiratory depression that occ...
Eligibility Criteria
Inclusion
- American Society of Anesthesiologists (ASA) class I, II or III
- Undergoing thoracic surgery on an inpatient basis
- Age 18 up to 85 years of age
Exclusion
- Subject is pregnant and/or lactating
- Subject has a serious Central Nervous System (CNS)pathology/trauma that, per clinical judgment of the investigator, precludes responsiveness or survival.
- Subject for whom alpha-2 agonists are contraindicated
- Subject meets any of the following cardiovascular criteria:
- Acute unstable angina (defined during current hospital stay)
- Suspicion of acute myocardial infarction.
- Considered to have a left ventricular ejection fraction of less than 30%.Decision to exclude is predicated in the Investigator's opinion, and may be based on any combination of acute presentations, recently preformed diagnostic studies, or a history that suggests poor cardiac function. Pulmonary congestion of a non-cardiac origin or mild congestive failure primarily attributable to etiologies other than poor ventricular function are not exclusion criteria.
- Subject has participated in a trial with any experimental drug within 30 days prior to enrollment in the study, or has ever been enrolled in this study.
- Subject is unable to undergo any procedures required by the protocol.
- Subject has acute hepatitis, a history or presence of chronic hepatitis, and /or has had a positive result for Hepatitis B surface antigen test.
- Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD).
- Subject has a known, uncontrolled seizure disorder.
- Subject has a known psychiatric illness that could confound a normal response to sedative treatment.
- Subject is terminally ill with a life duration expectancy of \< 60 days.
- Subject has a history of Obstructive Sleep Apnea.
- Oxygen saturation is \< 90% on room air.
- Subject is on beta blocker medication.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00345384
Start Date
May 1 2008
End Date
January 1 2010
Last Update
February 8 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor University Medical Center - Department of Anesthesiology
Dallas, Texas, United States, 75246